GB/T 45481-2025 Active National standards

GB/T 45481-2025 Silicone rubber compounds—Application for medical catheters

GB/T 45481-2025 Silicone rubber compounds—Application for medical catheters

Publish Date: 2025-03-28 Implement Date: 2025-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: GB/T 45481-2025
Standard Type: National standards
Standard Status: Active
is_force_gb: no
CCS Name: Synthetic rubber
ICS Name: Rubber
Publish Date: 2025-03-28
Implement Date: 2025-10-01
Pages: 12 pages

Scope

This document specifies the naming, technical requirements, inspection rules, and marking, packaging, transportation, and storage of silicone rubber compounds for medical catheters, and describes the corresponding test methods.
This document is applicable to the preparation of silicone rubber compounds for temporary and short-term contact medical catheters (hereinafter referred to as "compounds").
Note: According to the "Classification Rules for Medical Devices", medical catheters are classified as Class II medical devices in this document.

Development Information

Word Count: 15 Thousand words Pages: 12 pages

Referenced Standards

GB/T 528-1998 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties GB/T 528-2009 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties GB/T 529-1999 Rubber,vulcanized or thermoplastic—Determination of tear strength (Trouser,angle and crescent test pieces) GB/T 529-2008 Rubber,vulcanized or thermoplastic—Determination of tear strength(Trouser,angle and crescent test pieces) GB/T 531.1-2008 Rubber,vulcanized or thermoplastic—Determination of indentation hardness—Part 1:Duromerer method(Shore hardness) GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 28112-2011 Determination of residual dimethylcyclosiloxane volatiles in silicone rubber GB/T 32365-2015 Silicone rubber compound—Classification and system nomenclature

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